Early phase clinical trial to test the feasibility of an ACT-based physical activity promotion program for adults with depressive symptoms

早期临床试验旨在测试基于 ACT 的体力活动促进计划针对患有抑郁症状的成年人的可行性

• 批准号: 10462685
• 负责人: David M Williams
• 金额: $ 35.4万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462685
• 关键词: Accelerometer; Address; Adherence; Adoption; Adult; Aftercare; Age; Attention; Awareness; Behavioral; Benchmarking; Chronic; Chronic Disease; Client satisfaction; Clinical Practice Guideline; Clinical Trials; Data; Data Collection; Dementia; Depressed mood; Development; Distress; Economic Burden; Education; Educational Intervention; Enrollment; Fostering; Frequencies; Future; Goals; Health education; Individual; Intervention; Maintenance; Manuals; Mediator of activation protein; Mental Depression; Monitor; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Participant; Persons; Phase; Philanthropic Fund; Physical activity; Population; Procedures; Productivity; Protocols documentation; Psychologist; Questionnaires; Randomized; Research; Risk; Running; Site; Symptoms; Time; Training; Treatment Protocols; Work; base; behavior change; chronic back pain; clinically significant; community based treatment; depressive symptoms; disability; distress tolerance; early phase clinical trial; ethnic minority; exercise intervention; experience; feasibility testing; feasibility trial; follow-up; mindfulness; motivational enhancement therapy; negative affect; pilot test; primary outcome; programs; racial and ethnic; recruit; response; treatment group; treatment trial; trial comparing

ABSTRACT Up to 25% of U.S. adults have clinically significant depressive symptoms5,6 and people who experience these symptoms are at increased risk of all-cause mortality7 and chronic disease8-23 Engaging in regular physical activity (PA) can help alleviate depressive symptoms27-31 and reduce risk of chronic diseases, such as CVD32-36 and type 2 diabetes,37-41 that are associated with depression. Despite the benefits of PA for those with depressive symptoms, depressive symptoms consistently predict PA nonadherence.42-45 Factors such as decreased distress tolerance46-52 and low motivation53-60 make adherence to regular PA particularly difficult for adults with depressive symptoms. Thus, an important problem that needs to be addressed is how to help adults with depressive symptoms overcome barriers to regular PA. Acceptance and Commitment Therapy (ACT)61,62 is a mindfulness-informed intervention that is efficacious for fostering behavior change in various healthy populations and for treating depression. ACT enhances motivation for functional activities in depressed individuals by helping them to clarify personal values consistent with behavioral goals, and foster present- moment, nonjudgmental awareness (i.e., mindfulness) and acceptance of internal experiences to increase distress tolerance. These foci of ACT may be applied to address the intolerance of negative affective response to PA and low motivation for PA that serve as barriers to regular PA among adults with depressive symptoms. The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based ACTivity to PA+Education among 60 low-active adults (ages 18-65) with elevated depressive symptoms at two Greater Providence YMCA branches. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities. Aim 1: Develop and demonstrate training and intervention fidelity procedures for bachelor’s level interventionists to direct the ACTivity and PA+Education interventions. Aim 2: Demonstrate feasibility of recruitment, randomization, retention, and data collection procedures to conduct an individually randomized group treatment trial (IRGT). Aim 3: Demonstrate credibility (i.e., how convincing and logical a treatment seems) and acceptability of the ACTivity and PA+Education programs. Impact: The proposed research is a necessary step to prepare for a future multi-site RCT that has the potential to change clinical practice guidelines if shown to be effective. Specifically, if shown to be effective, ACTivity will provide a community- based treatment that can be delivered at local YMCAs by bachelor’s level staff to increase MVPA among depressed adults and thereby decrease their risk for chronic disease.

抽象的 多达25％ 症状有增加全因死亡率的风险7和慢性病8-23从事常规身体 活动（PA）可以帮助减轻抑郁症状27-31并降低慢性疾病的风险，例如CVD32-36 和2型糖尿病，37-41与Dep相关的糖尿病，因为PA对患有患者的好处 抑郁症状，抑郁症状合并预测PA不遵守。42-45个因素，例如 降低遇险公差146-52和低动机53-60使遵守规则难以实现 因此，患有抑郁症状的成年人。 患有抑郁症状的成年人再次出现 （ACT）61,62是一种正念信息的介入，是有效的促进行为改变了各种 健康的人群和治疗剥夺的行为。 通过帮助他们澄清与行为一致的个人价值观，并促进当前的个人价值观 - 时刻，非判断性的意识（即正念）和内部经验的满意 遇险耐受性。 PA和PA的低动力，这是抑郁症状的成年人中常规PA的障碍。 该项目的目标是收缩可行的清晰比较基于小组的活动与 PA+在60名低活动成年人（18-65岁）中的教育，抑郁症状升高，两个更大 Providence YMCA分支机构将被随机分配到治疗条件，持续6个月 包括为期8周的治疗，并获得6个月的基督教青年会会员资格，以等同于访问PA设施。 目标1：开发并展示培训和实践忠诚程序的学士学位 干预主义者指导活动和PA+教育间隔。 招聘，随机分组，保留和数据收集程序，以转换单个随机分组 小组治疗试验（IRGT）。 似乎是活动和PA+教育计划的可接受性。 为未来的多站点RCT做准备的必要步骤 如果证明是有效的，如果证明是有效的，活动将为社区提供 学士学位员工可以在当地YMCA进行基于基于的治疗方法，以增加MVPA 成年人降低了慢性疾病的风险。

项目成果

Testing the Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention to Increase Physical Activity among Individuals with Depression: A Protocol Paper.

• DOI: 10.1016/j.mhpa.2022.100475
• 发表时间: 2022-10
• 期刊: Mental health and physical activity
• 影响因子: 4.7
• 作者: Lisa R. LaRowe;Lauren Connell Bohlen;B. Gaudiano;Ana M. Abrantes;M. Butryn;S. Dunsiger;Elizabeth Griffin;E. Loucks;L. Uebelacker;Dave Williams